In a Warning Letter, FDA cited “significant violations” of CGMP regulations, including several repeat observations, at three Novartis facilities. The violations included failure to prevent microbiological contamination of sterile drug products, failure to investigate out-of-specification batches, failure to clean and maintain equipment, and failure to ensure drugs’ identity, strength, quality, and purity.
FDA officials observed the violations during three inspections of Novartis’s Sandoz unit in Broomfield, Colorado; Wilson, North Carolina; and Boucherville, Canada. The inspections took place on three occasions from April to August 2011.
All three violations cited at the Boucherville facility were repeat observations from a July 2009 FDA inspection. In the Warning Letter, FDA noted that the firm had neglected to investigate batch failures or implement corrective actions. For example, Novartis failed to determine the cause of the crystallization of an injectable solution, according to the letter. “We are concerned that your firm lacks process understanding to consistently manufacture” the product, FDA wrote. “Your failure to implement appropriate corrective actions and prevent future recurrence is indicative of an ineffective quality system,” the agency added.
The Wilson and Broomfield plants failed to ensure that their products had the appropriate strength, quality, and purity. These observations were repeat violations from an August 2008 Warning Letter.
In addition, investigators observed that several pieces of equipment at the Broomfield facility “were still dirty after cleaning had been completed and verified by a supervisor,” according to the letter. Although the company claimed that the insufficient cleaning was an isolated instance, the letter noted that it was a repeated violation from the August 2008 Warning Letter. “We are concerned that your firm has been cited for inadequate cleaning during a number of previous inspections, and that you have promised corrective actions but our inspections continue to reveal problems in this area of CGMP,” said the letter.